NCT05083858

Brief Summary

The aim of this study is to compare the effectiveness of Cervical Stabilization and Oculomotor Exercises in addition to the classical physiotherapy on pain severity, cervical joint position sense, posture, cervical joint range of motion, strength and endurance of deep cervical flexor muscles, static and dynamic balance, neck awareness, functional disability and patient satisfaction in individuals with chronic neck pain. When the literature is examined, there is no study comparing the effectiveness of cervical stabilization and oculomotor exercises in individuals with chronic neck pain. However, it has also attracted our attention that a progressive and dynamic program was not followed in studies stating the oculomotor exercise program. In this sense, The study is important in terms of both comparing the effects of these 3 treatments and presenting a progressive and dynamic exercise protocol to the literature.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 19, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

October 19, 2021

Status Verified

October 1, 2021

Enrollment Period

2 months

First QC Date

September 27, 2021

Last Update Submit

October 7, 2021

Conditions

Keywords

Chronic Neck PainProprioseptionExerciseStabilizationOculomotor

Outcome Measures

Primary Outcomes (1)

  • Cervical Joint Position Sense

    Joint Position Sense of flexion-extension, right-left rotation and right-left lateral flexion movements of the cervical region will be evaluated. A laser marker will be used to perform the assessment. The target angle for cervical flexion, extension and right-left rotation joint position sense measurement is 30°, and 20° for right-left cervical lateral flexion. Measurements will be made with eyes open and eyes closed. Before the JPS evaluations, the method will be explained to the individuals in detail and a sufficient number of trials will be made before the tests. Considering that fatigue may affect the results, all individuals will be warned not to forcefully move their neck and back muscles before the measurement. In order to prevent proprioceptive input, they will be asked to come in comfortable clothes that do not wrap around the neck on the day of their evaluation.

    Change from Cervical Joint Position Sense at the end of 8 weeks

Secondary Outcomes (10)

  • Pain Intensity

    Change from Pain Intensity at the end of 8 weeks

  • Craniovertebral Angle

    Change from Craniovertebral Angle at the end of 8 weeks

  • Cervical Joint Range of Motion

    Change from Cervical Joint Range of Motion at the end of 8 weeks

  • Strength and Endurance of the Deep Cervical Flexor Muscles

    Change from Strength and Endurance of the Deep Cervical Flexor Muscles at the end of 8 weeks

  • Static Balance

    Change from Static Balance at the end of 8 weeks

  • +5 more secondary outcomes

Study Arms (3)

Classical Physiotherapy Program + Cervical Stabilization Exercises

EXPERIMENTAL

In addition to classical physiotherapy, Cervical Stabilization Exercises will be applied to the individuals in the 1st group.

Other: Classical Physiotherapy Program + Cervical Stabilization Exercises

Classical Physiotherapy Program + Oculomotor Exercises

EXPERIMENTAL

In addition to classical physiotherapy, Oculomotor Exercises will be applied to the individuals in the 2nd group.

Other: Classical Physiotherapy Program + Oculomotor Exercises

Classical Physiotherapy Program

ACTIVE COMPARATOR

Only the classical physiotherapy program will be applied to the individuals in 3rd group.

Other: Classical Physiotherapy Program

Interventions

First of all, patients will be taught correct craniocervical flexion movement without activation of superficial muscles in different positions (supine, prone, crawling, sitting, standing). The program will be continued by asking to maintain the cranio-cervical flexion position during all movements. In order to gain dynamic stabilization, unilateral, bilateral, contralateral, ipsilateral and reciprocal extremity movements will be added to the program together with craniocervical flexion movement. Resistance will be added to the exercises as control of the movement is achieved. The exercises will progress from static to dynamic, from stationary floors to moving floors, from simple movements to complex movements.

Also known as: Cervical Stabilization
Classical Physiotherapy Program + Cervical Stabilization Exercises

Oculomotor Exercises is a program consisting of exercises that support proprioception in the cervical region. It consists of 4 main contents; Sacadic Eye movements, Gaze stability, Head/eye coordination, Head repositioning exercise.

Also known as: Oculomotor Exercises
Classical Physiotherapy Program + Oculomotor Exercises

Conventional TENS will be applied to apply analgesic current. TENS application will be made to the cervical paravertebral region, using four 5 x 5 cm adhesive surface electrodes, at 80 Hz frequency for 20 minutes, 100 msec. All participants will be asked to lie in a prone position. The neck will be in a neutral position. The hot pack will be applied to the cervical region for 20 minutes. Classical massage will be applied for 20 minutes using the Swedish technique. The technique will be performed on the upper and neck region of the back with 3 strokes, 3 kneading and 3 strokes. The patient will be massaged while lying in the prone position. Stretching/Posture Exercises Exercises will be applied as a 5-10 minute warm-up-cool-down program at the beginning and end of the study. Cervical flexor, lateral flexor, rotator muscles, pectorals, inferior shoulder joint capsule will be stretched. In addition to this, posture exercises will also be done.

Also known as: Classical Physiotherapy
Classical Physiotherapy Program

Eligibility Criteria

Age30 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women between the ages of 30-55,
  • Neck pain for at least 3 months,
  • Sedentary or non-regular exercise habit (3 days a week, less than 30 min of physical activity per day)
  • According to the Numerical Pain Scale, the pain intensity is 4 cm and above

You may not qualify if:

  • Has received any physiotherapy program due to neck or back pain in the last 6 months,
  • Congenital anomaly in the cervical region (such as Klippel Feil Syndrome)
  • Having structural scoliosis at any level of the vertebral column,
  • Acute or chronic neurological deficits (sensory and motor loss),
  • With vertebrobasillary artery failure,
  • Thoracic Outlet Syndrome,
  • Any vestibular problem,
  • With marked diplopia and oculomotor muscle insufficiency,
  • Having a cervical rib,
  • Having a history of fractures in the cervical vertebrae,
  • Colorblind,
  • Suffering from whiplash injury,
  • Those with serious rheumatic diseases such as Ankylosing Spondylitis, Rheumatoid Arthritis
  • Having undergone spine surgery from any region,
  • Tumor or spinal cord compression due to another reason,
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Mediterranean University

Famagusta, 99450, Cyprus

Location

Related Publications (4)

  • Jull GA, Falla D, Vicenzino B, Hodges PW. The effect of therapeutic exercise on activation of the deep cervical flexor muscles in people with chronic neck pain. Man Ther. 2009 Dec;14(6):696-701. doi: 10.1016/j.math.2009.05.004. Epub 2009 Jul 25.

    PMID: 19632880BACKGROUND
  • Revel M, Minguet M, Gregoy P, Vaillant J, Manuel JL. Changes in cervicocephalic kinesthesia after a proprioceptive rehabilitation program in patients with neck pain: a randomized controlled study. Arch Phys Med Rehabil. 1994 Aug;75(8):895-9. doi: 10.1016/0003-9993(94)90115-5.

    PMID: 8053797BACKGROUND
  • Jull G, Falla D, Treleaven J, Hodges P, Vicenzino B. Retraining cervical joint position sense: the effect of two exercise regimes. J Orthop Res. 2007 Mar;25(3):404-12. doi: 10.1002/jor.20220.

    PMID: 17143898BACKGROUND
  • Strimpakos N, Sakellari V, Gioftsos G, Kapreli E, Oldham J. Cervical joint position sense: an intra- and inter-examiner reliability study. Gait Posture. 2006 Jan;23(1):22-31. doi: 10.1016/j.gaitpost.2004.11.019.

    PMID: 16311191BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Zafer Erden

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master of Science, Physiotherapist, Lecturer, Principal Investigator

Study Record Dates

First Submitted

September 27, 2021

First Posted

October 19, 2021

Study Start

August 1, 2021

Primary Completion

September 25, 2021

Study Completion

July 1, 2022

Last Updated

October 19, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations